Quality Control Manager Quanterix
Quanterix is a private, venture-funded company whose mission is to develop a game-changing diagnostic platform that combines proprietary single-molecule array (Simoa?) technology, multiplexing and full automation. Initially, the company intends to commercialize a fully automated instrument into the life science research market, offering a menu of single-plex and multiplex immunoassays exploiting the ultra-sensitivity of Simoa?. The second phase will involve commercialization of the instrument in the in-vitro diagnostics market. The successful candidate will have an opportunity to leverage his/her experience to significantly impact the development and commercialization of an exciting new technology and be a part of a rapidly growing company on a trajectory to have a major impact in the life science research and clinical diagnostics arenas.
This position is responsible for all Quality Control functions for an early stage diagnostics manufacturing company with a highly complex technology and extensive product portfolio. These functions include incoming materials inspection and testing, functional performance testing for in-process components and kits, component and kit lot release and routine product stability monitoring. The processes and documentation required to support these functions will be developed and proceduralized as part of this role. With platform commercialization, this QC position will be responsible for the day-to-day operations, in a highly cross-functional environment, that will result in high quality product, high levels of customer service and compliance. The ideal candidate will be an innovative leader with experience in Lean Manufacturing principles in addition to a depth of experience in fast-paced Quality Control environments.
ESSENTIAL JOB FUNCTIONS
Manage inspection and testing of incoming raw materials, including chemicals, biologicals and packaging and labeling materials
Manage functional performance testing for in-process reagent components and assay kits
Manage testing and value assignment process for calibrators, controls and panels
Manage batch record auditing and lot release processes for all components and kits distributed by Quanterix
Create and manage all necessary documentation (testing and inspection protocols and specifications, process documents, Certificates of Analysis) to create compliant Quality Control processes
Create and manage routine product stability program
MINIMUM JOB REQUIREMENTS
Bachelor?s Degree in Biology, Chemistry or related Life Sciences
10+ years experience in medical device industry
3-5+ years experience with immunoassay Quality Control operations
Experience with GMP- and ISO-certified manufacturing and Quality Control operations required
Experience with Risk Management and Validation required
Experience with Lean Manufacturing and Continuous Improvement a plus
You need excellent organizational, record keeping and communication skills ? Demonstrated creative critical thinker ? Demonstrated ability to work well within cross-functional teams as a team player ? Possess an ability to learn and master complicated concepts quickly and comfortably ? A strong work ethic, the ability to generate high quality data under tight deadlines, and a collaborative, proactive attitude.
You will be working in a fast-paced environment, on multiple projects, with some of the brightest minds in the business. You will have an opportunity to develop breakthrough products and impact the successful development of a new disruptive technology in its early stages. You will be a part of a rapidly growing company on a trajectory to have a major impact in the life science research and clinical diagnostics arenas.
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